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Tyrosine Kinase Inhibitor

Alectinib for Non-Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Justin Gainor, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing two drugs to see if they can treat advanced NSCLC.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants treated with the combination of alectinib and bevacizumab with adverse events
Recommended phase II dose of the combination of Alectinib and Bevacizumab
Secondary outcome measures
Central nervous system disease control rate
Central Nervous System
Central nervous system progression-free survival
+6 more

Side effects data

From 2018 Phase 3 trial • 119 Patients • NCT02604342
24%
Fatigue
22%
Alopecia
16%
Asthenia
16%
Nausea
11%
Neutropenia
11%
Myalgia
11%
Decreased appetite
11%
Anaemia
11%
Constipation
11%
Cough
8%
Pruritus Generalised
8%
Pyrexia
8%
Paraesthesia
8%
Arthralgia
8%
Headache
5%
Pain in extremity
5%
Vomiting
5%
Tinnitus
5%
Febrile neutropenia
5%
Musculoskeletal Chest Pain
5%
Back pain
5%
Diarrhoea
5%
Dizziness
5%
Drug Hypersensitivity
5%
Oedema peripheral
5%
Neuropathy peripheral
3%
Gastroenteritis
3%
Abdominal pain
3%
Nasopharyngitis
3%
Stomatitis
3%
Upper Respiratory Tract Infection
3%
Lung infection
3%
Pneumonia bacterial
3%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Comparator: Premetrexed/Docetaxel
Experimental: Alectinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alectinib and Bevacizumab.Experimental Treatment2 Interventions
Phase 1 Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Alectinib, orally, twice a day, per cycle Bevacizumab, iv, once per cycle Phase II In the phase II portion of this study, the investigators will evaluate the combination of alectinib plus bevacizumab in ALK-positive patients with untreated or progressive, asymptomatic brain metastases. Eligible participants will receive alectinib plus bevacizumab at the recommended phase II doses determined in the phase I portion of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Alectinib
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,452 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,856 Total Patients Enrolled
Justin Gainor, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
Harvard Medical School (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
Justin Gainor, MD 2015. "Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02521051.
All > Anaplastic Ependymoma
~5 spots leftby Apr 2025
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